CLASS II Device recall · Reported 8 Aug 2012 · FDA Enforcement Report

Altus Floral Skin Markers recalled by Beekley

Beekley is recalling Altus Floral Skin Markers, distributed nationwide in the US. The recall was initiated on 9 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: A004

Quantity recalled6420 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2112-2012
FDA event ID: 62526
Recalling firm: Beekley, Bristol, CT
Classification: Class II
Status: Terminated
Recall initiated: 9 Jul 2012
FDA classified: 30 Jul 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

9 Jul 2012	Recall initiated by company
30 Jul 2012	Classified by FDA	+21 days
8 Aug 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Digital Skin Mammography Marker separating from the backing of the spot material

Product as listed by the FDA

Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Digital Skin Mammography Marker separating from the backing of the spot material

Which lots are affected?

Lot Numbers: A004

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 62526

Reported	Class	Recall	Company	Reason	Where
8 Aug 2012	CLASS II	S-Spots Floral Skin Markers recalled by Beekley	Beekley	Other	Nationwide
8 Aug 2012	CLASS II	A-Spots Floral Skin Markers recalled by Beekley	Beekley	Other	Nationwide
8 Aug 2012	CLASS II	O-Spots Floral Skin Markers recalled by Beekley	Beekley	Other	Nationwide

More recalls from Beekley

All 10

Reported	Class	Recall	Company	Reason	Where
22 Aug 2018Device	CLASS II	O-spot REF 791, 791S Adhere to skin for marking recalled by Beekley	Beekley	Other	Nationwide
22 Aug 2018Device	CLASS II	TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere recalled	Beekley	Other	Nationwide
22 Aug 2018Device	CLASS II	S-spot REF 777, 777S Adhere to skin for marking recalled by Beekley	Beekley	Other	Nationwide
14 Jun 2017Device	CLASS III	Medical 0-SPOT Mammography Skin Markers recalled by Beekley	Beekley	Other	9 states
18 Jun 2014Device	CLASS III	Spots Light Image O-Spots for Mammography recalled by Beekley	Beekley	Labeling Errors	6 states

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